On June 17, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, reported the presentation of results from its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel (Press release, Lutris Pharma, JUN 17, 2025, View Source [SID1234653961]). The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for use by patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash. The clinical data will be released in an oral presentation during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, being held July 2-5 in Barcelona, Spain.

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Presentation Details:

Presentation Title: A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies
Presenting Author: Dr. Ofer Purim, Head of Gastrointestinal Malignancy Unit at the Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem, Israel
Abstract Number: 50
Session Title: Proffered Paper Session
Session Date: Friday July 4, 2025
Session Time: 5:30 – 5:40 pm CET
Session Location: Madrid Room
About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

On June 17, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported the company has appointed Roger Sidhu, MD, as Chief Medical Officer (Press release, Cardiff Oncology, JUN 17, 2025, View Source [SID1234653945]). Dr. Sidhu is a veteran executive and clinician with over 20 years of experience and a strong track record of success in oncology research, development, and regulatory strategy. Dr. Sidhu succeeds Dr. Fairooz Kabbinavar who will remain with the company in an advisory role. The company also announced it will share additional clinical data from its lead program in RAS-mutated mCRC on July 29, 2025.

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"We are pleased to welcome Dr. Sidhu to lead the clinical program for onvansertib through the next phase of development. Dr. Sidhu is a respected clinician and seasoned executive with a proven track record of advancing innovative therapies through late-stage clinical development across multiple therapeutic areas including in first-line mCRC. As we move forward, we thank Dr. Kabbinavar for his leadership in progressing onvansertib’s clinical development across multiple tumor types," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "In addition to today’s medical leadership transition, we are announcing our plan to share an update of clinical data from the ongoing CRDF-004 trial on July 29, at which point we expect to release a substantive dataset."

"I am honored to join the executive team at Cardiff Oncology as we advance onvansertib through late-stage clinical development, and make a meaningful impact for patients living with cancer," said Roger Sidhu, MD. "With a strong foundation already in place, I’m stepping into this role at an exciting time as we prepare to share a clinical update on our lead program in RAS-mutated mCRC next month."

Dr. Sidhu was most recently the Chief Medical Officer and acting CEO at Treadwell Therapeutics. Previously, Dr. Sidhu spent nearly 10 years at Amgen in roles of increasing responsibility in the Hematology/Oncology therapeutic area where he advanced multiple therapeutic candidates. In mCRC, he led multiple phase 3 clinical trials of panitumumab (Vectibix) in monotherapy and in combination with chemotherapy leading to approvals in the U.S. and globally. Dr. Sidhu was also a leader in advancing the science of RAS biology and therapeutics in mCRC and has published work in several peer reviewed journals including the New England Journal of Medicine.

In addition, Dr. Sidhu served as Executive Vice President and Chief Medical officer at Roivant Sciences. He was also the Chief Medical Officer at Eterna Therapeutics, Inc. and Cell Design Labs, up until its acquisition by the Gilead subsidiary Kite, where he subsequently served as VP, Clinical Development.

Dr. Sidhu is a Fellow of the Royal College of Physicians and Surgeons of Canada in both internal medicine and medical oncology. He earned his medical degree from Queen’s University in Kingston, Ontario Canada and his bachelor’s degree in biochemistry from the University of Alberta in Edmonton, Alberta. Dr. Sidhu trained in internal medicine at Queen’s University and medical oncology at the British Columbia Cancer Agency in Vancouver, British Columbia and the Cross Cancer Institute in Edmonton, Alberta.

Conference Call and Webcast on Additional Clinical Data from CRDF-004 in mCRC

Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share additional clinical data from the CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at View Source A replay will be available in the investor relations section on the company’s website following the completion of the call.

Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

In connection with Dr. Sidhu joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock options to purchase 600,000 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock option was granted as an inducement material to Dr. Sidhu becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The option was granted as of June 16, 2025 and has an exercise price of $3.86 per share, the closing price on the grant date. The option vests over four years with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36-months, subject to Dr. Sidhu’s continued employment with Cardiff Oncology on such vesting dates.

On June 17, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its executive team will participate in the upcoming investor conferences, detailed below (Press release, Innate Pharma, JUN 17, 2025, View Source [SID1234653962]).

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H.C. Wainwright 3rd Annual Immune Cell Engager Virtual Conference
Dates: June 24, 2025 | Virtual

Wolfe Research Virtual Biotech Day
Dates: June 26, 2025 | Virtual

On June 16, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing circular RNA technology for gene and cell therapy and mutant RAS-targeting cancer vaccines, reported that interim data from the TG01 phase 1/2 clinical trial in multiple myeloma at Oslo University Hospital (OUS) has been presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 annual meeting in Milan, Italy (Press release, Circio, JUN 16, 2025, View Source [SID1234653913]).

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The results show preliminary signals of clinical efficacy for TG01 vaccination and confirm an excellent safety profile, thus providing justification for continued clinical development for a major unmet medical need. The trial is a collaboration between OUS and Circio to test TG01/QS-21 vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients with remaining measurable disease after completion of standard of care treatment. The aim is to assess whether T-cell responses to mutant RAS induced by TG01 can enhance and prolong the clinical benefit. OUS is the study sponsor, with Dr. Hanne Norseth as the primary investigator.

"RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population," said Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group "Interim data from the first twelve patients demonstrate the capability of TG01 to induce RAS-specific T-cell responses in a subset of patients, and suggest that these responses are associated with disease stabilization. This is an important early indication of clinical benefit. We look forward to completing the study, including a broad set of genetic and immunological analyses, which will help us build the understanding of how TG01 vaccination can fit as a future treatment option to deepen and prolong responses in this underserved patient population."

Oncogenic RAS mutations drive up to 30% of all cancers and an estimated 15-20% of multiple myelomas, and remain a major unmet medical need with few effective treatment alternatives. Circio has previously been awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council to advance the TG mutant RAS cancer vaccine program. These grants have provided funding towards two active clinical studies, including the present multiple myeloma study at OUS, Norway, and a phase 2 trial at Georgetown University, Washington D.C. USA, where TG01 is tested in pancreatic and lung cancer.

"Consistent with our prior observations in pancreatic cancer, it is very reassuring that this early-stage multiple myeloma trial has generated results showing immunological activity of the TG01 vaccine associated with clinical benefit," said Dr. Victor Levitsky, Chief Scientific Officer of Circio Holding ASA. "The biomarker findings are consistent with the current understanding of tumor immune control requiring a proper match between the characteristics of the tumor and the of patient´s genetic buildup. This important connection provides a mechanistic validation of clinical benefit and suggests specific biomarkers to select patients who can benefit most from TG01 treatment in follow-up clinical studies. We will continue to pursue our strategy to develop TG01 through external partnerships in parallel with our core in house circular RNA program."

Poster title:
The phase I/II TG01-study: Vaccinating against RAS-mutated Multiple Myeloma

Presentation date and location:
14 June 2025, EHA (Free EHA Whitepaper) 2025 Annual Meeting, Milan – Italy

The main conclusions from the poster presentation were as follows:

Available data demonstrate excellent tolerability and safety of TG01/QS-21 vaccination
50% (6/12) of vaccinated patients show vaccine-induced specific T-cell responses against mutant K/N-RAS-peptides
50% (6/12) of patients remain on study with stable disease (SD), no objective responses have so far been observed
67% (4/6) of patients with SD had a K/N-RAS-peptide specific immune response by ELISPOT (1/2 negative patients fell very narrowly below positivity threshold)
Enrollment and analysis of the TG01 vaccine-specific responses are ongoing

On June 16, 2025 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", SSE: 600196, HKEX: 02196) reported that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy (Press release, Teva, JUN 16, 2025, View Source [SID1234653929]). Teva’s internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications.

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Under the terms of the agreement, which aims to accelerate clinical data generation, Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries. Teva retains all development, manufacturing and commercialization rights to the licensed molecule in the rest of the world. The strategic partnership presents a significant step forward in the global development of TEV-56278, giving Teva the opportunity to leverage Fosun Pharma-generated data in other geographies.

"This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva’s innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients."

Anti-PD1-IL2 fusion proteins like TEV-56278 represent a novel approach to cancer immunotherapy. TEV-56278 is designed to deliver IL-2 selectively to PD-1+ T cells, thus amplifying anti-tumor T-cell activity while minimizing off-target systemic toxicities. The targeted approach holds promise for improving outcomes for patients with a variety of oncology diseases.

"We are pleased to partner with Teva on the development of TEV-56278," said Xingli WANG, MD, PhD, Executive President of Fosun Pharma and CEO of the Global R&D Center, "This collaboration brings together Teva’s expertise in innovative drug development with Fosun Pharma’s strong oncology development experience and commercial capabilities in the China market, creating a powerful synergy to accelerate the delivery of this important therapy to patients globally."

About TEV-56278

TEV-56278 is an anti-PD-1 antibody-cytokine fusion protein designed to selectively deliver an interleukin-2 (IL-2), i.e., ATTENUKINE, to PD-1-expressing T cells within the tumor microenvironment. This targeted approach aims to amplify anti-tumor T-cell activity while minimizing systemic toxicities. TEV-56278 is being evaluated as a monotherapy and in combination with pembrolizumab. Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory.